Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation (MRI-AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mangosteen juice
placebo juice
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
Candidates for this study must meet all of the following criteria:
- Age >18 years
- Documented atrial fibrillation with a clinically indicated cardioversion.
- Anticoagulation with therapeutic INR or PTT as per Mayo Clinic cardioversion guidelines.
- Provision of written informed consent.
Exclusion Criteria:
Subjects will be excluded if any of the following conditions apply:
- Presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
- Myocardial infarction within 1 month, CABG or cardiac surgery including surgical maze or AF radiofrequency ablation within the past 3 months
- Presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
- History of bleeding diathesis or coagulopathy
- Known atrial thrombus or contra-indication to cardioversion
- Active infection or collagen vascular disease with active inflammation
- Current use of corticosteroids
- Gastrointestinal (GI) or genitourinary bleed within the past six months requiring transfusion
- Concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
- Known allergy to juice components
- Inability or refusal to cooperate with study procedures
- Unsuccessful cardioversion
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
mangosteen juice
placebo juice
Arm Description
subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient
subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient
Outcomes
Primary Outcome Measures
Test the hypothesis that the addition of mangosteen juice as a dietary supplement may reduce the measured levels of inflammatory biomarkers interleukin 1, interleukin 6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF a) etc).
Secondary Outcome Measures
attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).
Quality of life
AF recurrence rates between the mangosteen group and the placebo group
Associated levels of inflammatory markers with those experiencing recurrent AF
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00951301
Brief Title
Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation
Acronym
MRI-AF
Official Title
Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Significantly lower accrual rate than anticipated, time constraints.
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to see if the addition of mangosteen juice to standard medical care will reduce the risk of atrial fibrillation (AF) recurrence following direct current (DC) cardioversion. The study will also look at the effects the mangosteen juice may have on biomarkers of inflammation and endothelial cell dysfunction (the tissue lining the arteries does not function properly).
Detailed Description
Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial is a study designed to test the primary hypothesis that a dietary supplement (Mangosteen) containing anti-inflammatory and anti-oxidant properties may effect the measured levels of inflammatory biomarkers. Secondarily, this study will compare the attenuation of markers of endothelial cell dysfunction including endothelial progenitor cells (EPCs), clinical levels of anticoagulation (INR), digoxin, lipids, and glycosylated hemoglobin (Hgb A1c), quality of life measurements, AF recurrences, and associated levels of inflammatory markers with those experiencing recurrent AF between the mangosteen group and the placebo group.
This trial will randomize 250 patients presenting to the Mayo Clinic Cardioversion Unit over one year to two groups including a mangosteen supplemented group versus a control group with placebo juice. Patients will be enrolled who have a history of paroxysmal, persistent, or longstanding persistent atrial fibrillation and excluded if they have a history of recent surgery, myocardial infarction, infection, collagen vascular disease with active inflammation, or thyroid disease. Furthermore, patients already on corticosteroids will be excluded. Patients will be evaluated at enrollment and followed at 3 months and 6 months with repeat ECG, laboratory testing of inflammatory biomarkers and endothelial function, as well as quality of life questions.
The trial will track the effect of natural juices containing anti-inflammatory and anti-oxidant properties on inflammatory markers, endothelial progenitor cells, and quality of life. This trial will attempt to determine if any dietary supplement effects to inflammatory markers correlate with the rate of recurrent AF in each of the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mangosteen juice
Arm Type
Active Comparator
Arm Description
subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient
Arm Title
placebo juice
Arm Type
Placebo Comparator
Arm Description
subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient
Intervention Type
Drug
Intervention Name(s)
mangosteen juice
Other Intervention Name(s)
Xango juice
Intervention Description
6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.
Intervention Type
Drug
Intervention Name(s)
placebo juice
Intervention Description
6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.
Primary Outcome Measure Information:
Title
Test the hypothesis that the addition of mangosteen juice as a dietary supplement may reduce the measured levels of inflammatory biomarkers interleukin 1, interleukin 6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF a) etc).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).
Time Frame
6 months
Title
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).
Time Frame
6 months
Title
Quality of life
Time Frame
6 months
Title
AF recurrence rates between the mangosteen group and the placebo group
Time Frame
6 months
Title
Associated levels of inflammatory markers with those experiencing recurrent AF
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Candidates for this study must meet all of the following criteria:
Age >18 years
Documented atrial fibrillation with a clinically indicated cardioversion.
Anticoagulation with therapeutic INR or PTT as per Mayo Clinic cardioversion guidelines.
Provision of written informed consent.
Exclusion Criteria:
Subjects will be excluded if any of the following conditions apply:
Presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
Myocardial infarction within 1 month, CABG or cardiac surgery including surgical maze or AF radiofrequency ablation within the past 3 months
Presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
History of bleeding diathesis or coagulopathy
Known atrial thrombus or contra-indication to cardioversion
Active infection or collagen vascular disease with active inflammation
Current use of corticosteroids
Gastrointestinal (GI) or genitourinary bleed within the past six months requiring transfusion
Concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
Known allergy to juice components
Inability or refusal to cooperate with study procedures
Unsuccessful cardioversion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A Bauer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation
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